Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/02—Halogenated hydrocarbons
  • A61K31/025—Halogenated hydrocarbons carbocyclic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
  • A61K9/0026—Blood substitute; Oxygen transporting formulations; Plasma extender
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

• Burn wounds in patients are difficult to effectively treat. Tissue damage can occur in the burn wound after the initial heat and mediator damage. In addition, as well as infections, many other complications are associated with burns after the initial injury. Furthermore, burn wounds can require extended hospitalization and/or bed rest. Bed rest in turn exacerbates some problems of burn wound healing.
• a method for treating a burn injury of a subject comprising immersing the subject in a liquid composition comprising an oxygenated perfluorocarbon so as to thereby treat the burn injury.
• a method for treating a burn injury of a subject's skin comprising immersing the skin burn injury in a liquid composition comprising an oxygenated perfluorocarbon so as to thereby treat the skin burn injury.
• a method for reducing skin scarring associated with a skin burn injury in a subject comprising immersing the skin burn injury in a liquid composition comprising an oxygenated perfluorocarbon so as to thereby treat the skin burn injury and thereby reduce the skin scarring.
• Burn wound treatments are described in section 20, chapter 276, of The Merck Manual, 17 th Edition (1999), Merck Research Laboratories, Whitehouse Station, N.J., U.S.A. which is hereby incorporated by reference.
• “Burn injury” as used herein is a first, second or third degree wound caused by thermal heat, radiation, electric or chemical heat, for example as described at page 2434, section 20, chapter 276, of The Merck Manual, 17 th Edition (1999), Merck Research Laboratories, Whitehouse Station, N.J., U.S.A.
• Skin scarring associated with a skin burn injury is the skin scarring response that results from a second or third degree burn.
• Mechanismally circulated means the action of moving a fluid in a closed circuit by means of a physical force.
• Frtered as used herein means the action of passing a fluid through a physical filter, mesh or absorbent substance, so as to remove cell debris, bacteria, pathogenic organisms and/or waste products.
• “Promotes alleviation of pain” as used herein means a decrease in the subject's experience of pain resulting from the burn injury.
• “Accelerates healing” as used herein means an increased rate of burn injury/wound repair and healing as compared to the rate of burn injury/wound repair and healing in an untreated control subject.
• Perfluorocarbons include perfluoro-tert-butylcyclohexane (C 10 F 20 ) which is available, for example, as OxycyteTM from Oxygen Biotherapeutics Inc., Costa Mesa, Calif.
• the Perfluoro-tert-butylcyclohexane has the following structure:
• liquid perfluorocarbon compositions may comprise pharmaceutically acceptable carrier or cosmetic carrier and adjuvant(s) suitable for topical administration.
• compositions suitable for topical administration are well known in the pharmaceutical and cosmetic arts. These compositions can be adapted to comprise the oxygenated perfluorocarbon.
• compositions of the methods or uses described herein are in liquid form and are suitable for having gases bubbled through them.
• Non-liquid compositions that contain liquids but do not behave like liquids, such as gels, hydrogels, foams and creams and other semi-solid compositions are specifically excluded from the phrase “liquid composition” as used herein.
• Emulsions and other liquids are included in the phrase “liquid composition” as used herein.
• oxygenated perfluorocarbon is a perfluorocarbon which is carrying oxygen at, for example, saturation or sub-saturation levels.
• composition employed in the methods described herein may comprise a pharmaceutically acceptable additive.
• Topical anesthetic means an anesthetic such as lidocaine.
• Antibacterial agent means a bactericidal compound such as silver nitrate solution, mafenide acetate, or silver sulfadiazine, or an antibiotic.
• the term “effective” as in an amount effective to achieve and end refers to the quantity of a component that is sufficient to yield a desired therapeutic response without undue adverse side effects (such as toxicity, irritation, or allergic response) commensurate with a reasonable benefit/risk ratio when used in the manner of this disclosure.
• an amount effective to promote burn wound healing without causing undue adverse side effects will vary with such factors as the particular condition being treated, the physical condition of the patient, the type of mammal being treated, the duration of the treatment, the nature of concurrent therapy (if any), and the specific formulations employed and the structure of the compounds or its derivatives.
• liquid composition containing a perfluorocarbon in the form of a perfluorocarbon emulsion in an embodiment of all the methods described herein.
• the perfluorocarbon is perfluoro-tert-butylcyclohexane.
• the subject is human.
• the perfluorocarbon is saturated with oxygen.
• the perfluorocarbon emulsions of the methods and uses of the invention include perfluorocarbon-in-water emulsions comprising a continuous aqueous phase and a discontinuous perfluorocarbon phase.
• the emulsions can include emulsifiers, buffers, osmotic agents, and electrolytes as well as the components described hereinabove.
• the perfluorocarbons are present in the emulsion from about 5% to 130% w/v. Embodiments include at least about 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80% and 85% w/v.
• a 60% w/v F-tert-butylcyclohexane emulsion may be used as the perfluorocarbon emulsion in one embodiment.
• Embodiments also include an egg yolk phospholipid emulsion buffered in an isotonic medium wherein the perfluorocarbon is present in the emulsion from about 5% to 130% w/v.
• Embodiments include at least about 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80% and 85% w/v.
• a 60% w/v F-tert-butylcyclohexane emulsion may be used as the perfluorocarbon emulsion in one embodiment of an egg yolk phospholipid emulsion buffered in an isotonic medium.
• a method for treating a burn injury of a subject comprising immersing the subject in a liquid composition comprising an oxygenated perfluorocarbon so as to thereby treat the burn injury.
• a method for treating a burn injury of a subject's skin comprising immersing the skin burn injury in a liquid composition comprising an oxygenated perfluorocarbon so as to thereby treat the skin burn injury.
• a method for reducing skin scarring associated with a skin burn injury in a subject comprising immersing the skin burn injury in a liquid composition comprising an oxygenated perfluorocarbon so as to thereby treat the skin burn injury and thereby reduce the skin scarring.
• the subject is partially immersed in the liquid composition. In embodiments of the instant methods, the subject is fully immersed in the liquid composition. In embodiments of the instant methods, the subject is artificially ventilated via intubation. In embodiments of the instant methods, the liquid composition accelerates healing of the burn injury. In embodiments of the instant methods, the liquid composition promotes alleviation of pain resulting from the burn injury. In embodiments of the instant methods, the liquid composition is located in a container and is mechanically circulated. In embodiments of the instant methods, liquid composition is filtered. In embodiments of the instant methods, the liquid composition is at body temperature. In embodiments of the instant methods, the liquid composition is cooled below ambient temperature. In embodiments of the instant methods, the liquid composition is heated above ambient temperature.
• the liquid composition is a pharmaceutical composition and comprises a pharmaceutically acceptable carrier.
• the liquid composition is a perflurocarbon emulsion.
• the perfluorocarbon emulsion has a particle size of about 0.3 microns or less.
• the perfluorocarbon emulsion has a particle size of about 0.05 to 0.1 microns.
• the liquid composition is bubbled with 1%-100% oxygen.
• the composition is bubbled with 100% oxygen.
• the composition further comprises a topical anesthetic.
• the composition further comprises an antibacterial agent.
• the perfluorocarbon is perfluoro-tert-butylcyclohexane.
• the subject is human.
• the invention also provides use of a perfluorocarbon in the manufacture of a liquid composition for treating a skin burn injury in a subject.
• the invention also provides use of a perfluorocarbon in the manufacture of a liquid composition for reducing scarring associated with skin burn injury in a subject.
• the liquid composition is a pharmaceutical composition and comprises a pharmaceutically acceptable carrier.
• the perfluorocarbon is perfluoro-tert-butylcyclohexane.
• the liquid composition is manufactured to be administered at 0.1° C. to 20.0° C. below the subject's body temperature.
• the liquid composition is manufactured to be administered at 0.1° C. to 4.0° C. above the subject's body temperature.
• the subject is human.
• a liquid perfluorocarbon composition is provided for use in treating as burn wound.
• the perfluorocarbon is perfluoro-tert-butylcyclohexane.
• perfluorocarbon liquid as a suspending fluid and supplier of oxygen to the damaged tissues of burn victims.
• PFCs Perfluorocarbons
• Such PFCs have been found to be efficient carriers of those gases, both as emulsions for intravenous use and as neat liquids for liquid ventilation applications.
• the burn victim or the burned portion of the victim e.g. a limb, is suspended in a large container of PFC sufficient to allow the patient or portion to float freely; this removes many typical problems related to the burn patient lying in a bed with burned skin pressed against bedding.
• Circulation of the perflurocarbon liquid can be employed so that the patient floats without constraints, alleviating pain associated with usual system of treatment.
• external heating or cooling of the fluid can be employed in order to maintain a comfort level for the patient.
• the fluid is preferably filtered to assure a biologically inert and/or sterile liquid environment for the patient.
• a gas mixture containing 0 to 100% oxygen from (with adequate controls and precautions for ultra-ambient levels) is bubbled in the circulating PFC to supply oxygen to the patient's skin.
• PFCs are excellent transporters of oxygen and carbon dioxide; being that the PFCs are slightly lipophilic at body temperature and would help in the transport of oxygen into and removal of carbon dioxide from the skin tissue, accelerating the healing process.
• a preferred PFC, F-tert-butylcyclohexane is only slightly lipophilic at body temperature and not lipophilic at room temperature.
• OxycyteTM is based on the perfluorocarbon F-tert-butylcyclohexane, a saturated alicyctic PFC (molecular formula C 10 F 20 ) and can be used as a PFC composition in the methods and uses described herein. Physical properties of F-tert-butylcyclohexane are as follows:
• a subject suffering from a burn injury is floated by immersion in a composition comprising an oxygenated perfluorocarbon.
• the composition is regularly circulated and filtered.
• the subject's burn injury heals, and accelerated/improved healing is seen relative to control subject's burn injury.
• the subject can be suffering from a burn injury to the skin, for example a second or third degree burn.
• a subject suffering from a burn injury to a limb is position so that the injured limb is immersed in a composition comprising an oxygenated perfluorocarbon.
• the composition is regularly circulated and filtered.
• the subject's burn injury heals, and accelerated/improved healing is seen relative to control subject's burn injury.
• the subject can be suffering from a burn injury to the skin of the limb which is a second or third degree burn.
• a subject suffering from a burn injury is floated by immersion in a composition comprising an oxygenated perfluorocarbon.
• the composition is regularly circulated and filtered.
• the subject's burn injury heals, and reduced skin scarring is seen relative to scarring resulting from a control subject's burn injury.

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• Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Epidemiology (AREA)
• Dermatology (AREA)
• Hematology (AREA)
• Inorganic Chemistry (AREA)
• Engineering & Computer Science (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Medicinal Preparation (AREA)

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Cited By (7)

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• 2009
  • 2009-09-16 US US13/063,348 patent/US20110229575A1/en not_active Abandoned
  • 2009-09-16 WO PCT/US2009/005162 patent/WO2010033187A1/fr not_active Ceased

Patent Citations (6)

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